Lessons on Urethral Lidocaine in Urodynamics (LULU)

Lessons on Urethral Lidocaine in Urodynamics (LULU): Impact of Intraurethral Lidocaine on Cystometric Parameters and Discomfort

This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Vaginal Vault Prolapse; Vaginal Prolapse; Urethra Issue
• Intervention / Treatment: Drug: Water-Based Vaginal Lubricant; Drug: lidocaine topical

Detailed Description

This trial is a randomized, double blind, controlled trial for patients undergoing complex cystometric evaluation. Patients will undergo routine complex cystometric evaluation for acquisition of baseline data using a small amount of intraurethral aqueous jelly for catheter lubrication. Then, they will be randomized to instillation of either placebo (additional intraurethral aqueous jelly, 5ml) or intraurethral 2% lidocaine jelly. Participants then undergo complex cystometry a second time. Normal variations in studies with placebo will be compared to variations within the 2% lidocaine jelly group to determine if cystometric parameters are altered in any clinically important ways. Patient discomfort will also be evaluated by both the patient and the urodynamics advanced practice nurse.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Christina M Hegan, APRN WHNP-BC; Phone Number: 214-645-3815; Email: christy.hicks@utsouthwestern.edu
• Study Contact Backup: Name: Agnes Burris, RN; Phone Number: 214-645-3833; Email: agnes.burris@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients
• >18 years of age
• Already scheduled (or being scheduled) for UDS to assess urinary incontinence
• Able to speak and read in English

Exclusion Criteria:

• Diagnosis of pelvic pain, interstitial cystitis, or bladder pain syndrome
• Known neurogenic disease impacting voiding/ continence (e.g., Parkinson disease, multiple sclerosis, myasthenia gravis, recent stroke)
• Active UTI
• Pelvic organ prolapse that is unable to be easily reduced
• Pregnancy or breastfeeding
• Allergy or hypersensitivity to lidocaine or local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water Based Lubricating Jelly; 5ml of Water Based Lubricating Jelly	Drug: Water-Based Vaginal Lubricant; 5cc water based jelly applied intraurethral
Active Comparator: Lidocaine 2% Jelly; 5ml of Lidocaine 2% Jelly	Drug: lidocaine topical; 5cc 2% lidocaine jelly applied intraurethral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensation as Indicated by the Volume of Water Filled (ml) at the Time of Patient Perception of First Sensation, First Urge to Void, Strong Urge to Void, and Full Bladder Capacity During Bladder Filling.	Assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (especially, strong desire to void).	Within same visit, approximately 90-120 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Perception of Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst the Pain Imaginable).	Determine whether the use of intraurethral lidocaine 2% jelly meaningfully impacts pain/discomfort measured by a visual analog scale during cystometry (catheter insertion and at maximum cystometric capacity), during pressure flow study (PFS), and post-procedure.	Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Provider Perception of Patient Pain/Discomfort as Indicated by Visual Analog Scale (Scale of 0-100 With 0 Being no Pain and 100 Being the Worst Pain Imaginable).	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts provider perception of patient discomfort.	Change from cystometrogram 1 to cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Detrusor Overactivity	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts the presence/absence of detrusor overactivity (bladder spasm) during urodynamic bladder testing. Detrusor overactivity was noted and compared between placebo and lidocaine jelly on UDS #2.	Cystometrogram 2 within same visit, approximately 90-120 minutes.
Filling Metrics: Number of Participants With Normal Bladder Compliance	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts bladder compliance (change in volume/ change in detrusor pressure (Pdet)). Compliance in UDS #2 was noted and compared in both groups: water-based lubricant and intraurethral 2% lidocaine jelly. Results indicate how many participants in which normal compliance was observed. *There were 3 missing data values in our data.	Within same visit, approximately 90-120 minutes.
Voiding Metrics: Maximum Flow Rate	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts maximum flow rate (mL/sec).	Within same visit, approximately 90-120 minutes.
Voiding Metrics: Voiding Pattern (Normal vs. Intermittent/Interrupted vs Prolonged) as Perceived by Provider Interpretation of Pressure Flow Study During Voiding Based on Seconds to Void and Whether Urine Stream is Constant or Intermittent/Interrupted.	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding pattern. Voiding pattern was assessed in UDS #2 and identified as either "normal", "prolonged", "intermittent", "interrupted" or a combination of those identifiers and compared between the two groups.	within same visit, approximately 90-120 minutes.
Voiding Metrics: Voided Volume and Post-void Residual	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voided volume and post-void residual (mL) as recorded during UDS #2.	Within same visit, approximately 90-120 minutes.
Voiding Metrics: Percentage of Voiding Efficiency	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts voiding efficiency, which is calculated as the voided volume (mL) divided by the sum of the voided volume (mL) and the post-void residual volume (mL). Voiding efficiency was compared by treatment arm in UDS #2.	Cystometrogram 2 within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Max	Determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts Pdet Max (cm/H2O) on UDS #2.	Within same visit, approximately 90-120 minutes.
Voiding Metrics: Pdet Peak Flow	Determine whether the use of intraurethral 2& lidocaine jelly meaningfully impacts Pdet Peak Flow (cm/H2O) on UDS #2.	Within same visit, approximately 90-120 minutes.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Christina M Hegan, APRN WHNP-BC, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• Hicks, C., Schaffer, J., Pruzynski, J., & Rahn, D. (2022). Impact of Intraurethral Lidocaine on Cystometric Parameters and Patient Discomfort: A Randomized Controlled Trial. Urologic Nursing, 42(5), 237-257. https://doi.org/10.7257/2168-4626.2022.42.5.237

Helpful Links

• Research Video

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): August 18, 2021
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Urination Disorders; Pathological Conditions, Anatomical; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Pelvic Floor Disorders; Cystocele; Uterine Prolapse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: STU-2019-0540

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes